Implantable anchoring device and methods of use

ABSTRACT

A method of using an implantable device provides an implantable device including a plurality of links ( 113, 115, 117, 119 ), a device closure pin ( 111 ), a lock-in unit ( 103 ) attached and located between two links, and a quick release unit ( 105 ) attached and located between two links. The plurality of links ( 113, 115, 117, 119 ), lock-in unit ( 103 ) and release unit ( 105 ) are constructed in a closed contour. The closed contour of the implantable device, in a rigid state ( 151 ), is a figure eight comprised of two arcs ( 125, 127 ) and two connected interconnecting sections ( 131, 133 ).

The present application is a continuation of U.S. patent applicationSer. No. 15/954,757 filed on Apr. 17, 2018 which claims the benefit ofU.S. Provisional Patent Application 62/613,065 to Kalfon, Ziv filed onJan. 3, 2018, both of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to a device which is insertedinto a body cavity using intraoral procedures and positioned within abody cavity by a deformation of the shape and rigidity of the device.

BACKGROUND OF THE DISCLOSURE

Several medical procedures require placement of a medical device in alumen of human or animal body and in particular in the stomach. Onceinserted, the movement of the inserted medical device has to beconstrained and this is achieved by use of anchors. U.S. Pat. No.9,636,245 describes a gastrointestinal device including a proximalelement configured to reside in the stomach and a distal elementconfigured to reside in an intestine, where the proximal element isconfigured to resist migration over time. US Pat. Application No.2008/0058840 describes an alternative proximal element for placementwithin a hollow body organ. The proximal element includes a memberhaving a first shape for delivery to the hollow body and a second shapefor implantation therein. The member has sufficient rigidity in itssecond shape to exert an outward force against an interior of the hollowbody so as to bring together two substantially opposing surfaces of thehollow body. The examples of implants described in U.S. Pat. No.9,636,245 and US 2008/0058840 suffer from migration within a lumen ofhuman body, and do not provide the long term required implantationstability.

SUMMARY

This current disclosure describes an implantable device including aplurality of links and configured to be in either of two modes; aflexible mode in at least one plane of the device or a rigid mode in allother planes of the device. The implantable device includes at least butnot limited to: device closure pin; a lock-in unit; a quick releaseunit; a plurality of links where each link is connected to two otherlinks or to a link on one side and either a lock-in unit or release uniton an opposing side. The implantable device is inserted into a bodycavity using intraoral procedures. During insertion, the device closurepin is attached only at one side and in one example to the quick releaseunit, and the implantable device is in the flexible in one plane mode.The flexibility of the implantable device affords the device the abilityto follow the contours of the body orifice and facilitates insertionwith minimal patient discomfort. The implantable device is releasableconnected to the intraoral insertion equipment at the lock-in unit.After insertion of the implantable device into the body and placement ofthe device in the target body cavity, the device closure pin is pulledinto the lock-in unit and locked into place. The device closure pin isnow attached at both sides and the implantable device is transformedinto a rigid mode providing anchoring features and preventing mobilityof the implantable device in the body cavity. In one example afunctional unit providing a body related function is attached to releaseunit. An example of a functional unit is an intragastric sleeve adaptedto reduce the intake of food items in the intestine.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an example of an implantable device consisting of a pluralityof links and configured to be flexible in at least one plane;

FIG. 1B is an example of an implantable device consisting of multiplelinks just prior to being configured to be rigid in all planes;

FIG. 1C is an example of an implantable device consisting of multiplelinks and configured to be rigid in all planes;

FIG. 2A is an example of a link of the implantable device;

FIG. 2B is an example of a top view of a link of the implantable device;

FIG. 2C is an example of a side view cross section of a link of theimplantable device at cut line NN from FIG. 2B;

FIG. 3A is an example of device closure pin attached to a release unit;

FIG. 3B is an example of a side view of a device closure pin attached toa release unit;

FIG. 3C is an example of a back view of a device closure pin attached toa release unit;

FIG. 4A is an example of device closure pin attached to a receptacle;

FIG. 4B is an example of a side view of a device closure pin attached toa receptacle;

FIG. 4C is an example of a top view of a device closure pin attached toa receptacle;

FIG. 5 is an example of a method of use of the implantable device in therigid state (151) to constrain movement of the device in a body cavity;

FIG. 6A is an example of the wave anchor (503) in a foldedconfiguration; and

FIG. 6B is an example of the wave anchor in an extended configuration.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative examples described in the detaileddescription, drawings, and claims are not meant to be limiting. Otherexamples may be utilized, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presented here.It will be readily understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in thefigures, can be arranged, substituted, combined, and designed in a widevariety of different configurations, all of which are explicitlycontemplated and make part of this disclosure. This disclosure is drawn,inter alia, to a device which is inserted into a human or animal bodyusing intraoral procedures and positioned within a body cavity by adeformation of the shape and rigidity of the device.

In examples/patents of the implantable devices described above, theproximal element is in contact with the pylorus. The shape of theproximal element is rounded and as a result it exerts an expansion forceon the pylorus which extends the pylorus opening over time and dislodgesthe proximal element. Such implants suffer from migration within a lumenof human or animal body, and do not provide the long term requiredimplantation stability. It is desirable to have a proximal element whichdoes have a rounded shape in contact with the pylorus and provides thelong term required implantation stability.

FIG. 1A is an example of an implantable device consisting of a pluralityof links and configured to be flexible in at least one plane. Theimplantable device includes at least but not limited to; a lock-in unit(103); a quick release unit (105); a plurality of links (101, 113, 115,117, 119) (FIG. 1B) where each link (101, 113, 115, 117, 119) isconnected to two other links (101, 113, 115, 117, 119) or to a link(101, 113, 115, 117, 119) on one side and either a lock-in unit (103) ora release unit (105) on an opposing side. The implantable device isinserted into a body cavity using intraoral procedures. During insertionthe flexibility of the implantable device affords the device the abilityto follow the contours of the body orifice and facilitates insertionwith minimal discomfort to the patient. The implantable device isconnected to delivery or insertion equipment at lock-in unit (103). Inone example a functional unit providing a body related function isattached to release unit (105). An example of a functional unit is anintragastric sleeve adapted to reduce the intake of food items in theintestine.

FIG. 1B is an example of an implantable device consisting of multiplelinks just prior to being configured to be rigid in all planes. Theimplantable device is transformed from a flexible mode as described inFIG. 1A to a rigid mode as described in FIG. 10 by pulling a chord (123)attached to device closure pin (111) (FIG. 1B) and passing throughlock-in unit (103). Device closure pin (111) follows the chord (123)into lock-in unit (103), where a locking mechanism holds the deviceclosure pin (111) in place. The locked in device closure pin (111)exerts a force on the implantable device links (101, 113, 115, 117,119), constricting the relative movement of the links and transitioningthe implantable device to a rigid mode. Transition of the implantabledevice from a rigid mode to a flexible mode facilitates removal of theimplantable device from the body cavity. Removal of release pin (111)from lock-in unit (103), releases the device closure pin from therelease unit (105) and transitions the implantable device to a flexiblemode. After transitioning the implantable device to a flexible mode itis removed from the body cavity with intraoral procedures. Examples ofmaterials for manufacturing the links (101, 113, 115, 117, 119) includebut are not limited to: Titanium; stainless steel; Cobalt chrome,Nitinol alloy, thermoset plastics and similar materials or compositionof said materials. In a further example the links are coated or coveredwith Teflon or other atraumatic materials. Examples of materials for thedevice closure pin (111) and the release pin (121) include but are notlimited to; stainless steel; titanium; Cobalt chrome, Nitinol alloy,thermoset plastics and similar materials or composition of saidmaterials. In one example the links (101, 113, 115, 117, 119) of theimplantable device are manufactured using additive manufacturingprocesses, for example 3D printing. Links (101, 113, 115, 117, 119),lock in unit (103), quick release unit (105) and interconnecting pinsare manufactured concurrently and in a connected manner so that at theadditive manufacturing cycle results in a connected closed contour oflinks (101, 113, 115, 117, 119), lock-in unit (103) and quick releaseunit (105).

Hence, described in one example is an implantable device including: aplurality of links (101, 113, 115, 117, 119); a device closure pin(111); a lock-in unit (103) attached and located between two links (117,119); a release unit (105) attached and located between two links (113,115); wherein the plurality of links (101, 113, 115, 117, 119), lock-inunit (103) and release unit (105) construct a closed contour; andwherein the implantable device is in flexible state when the deviceclosure pin (111) is coupled to the lock-in unit (103) or the releaseunit (105) and rigid state when the device closure pin (111) is attachedto both the lock-in unit (103) and release unit (105).

FIG. 1C is an example of a side view of the implantable device in therigid state (151), where the close contour forms and device closure pin(111) form a figure eight. In an alternative example an implantabledevice comprising; a plurality of links (101, 113, 115, 117, 119)constructing a closed loop wherein a link (101, 111, 113, 115, 117) isconnected to two other links (101, 113, 115, 117, 119); a device closurepin (111); wherein the implantable device is flexible when only one sideof device closure pin (111) is attached to a link (101, 113, 115, 117,119) and rigid when both sides of the device closure pin (111) isattached to a link (101, 113, 115, 117, 119). In a further example theclosed contour of an implantable device in a rigid state (151) is ovaland is configured to follow the shape of two arcs (125, 127) and twointerconnecting sections (131, 133) where the absolute radius of theinterconnecting sections (125, 127) is at least 5 times the absoluteradius of the arcs (125, 127). In a further example the radius of theinterconnecting sections (125, 127) is opposite the sign of the radiusof the arcs (125, 127). In a further example the closed contour of animplantable device in a rigid state is oval and comprised of two arcs(125, 127) and two interconnecting sections (131, 133) where the twointerconnecting sections (131, 133) are substantially straight. In afurther example the closed contour of an implantable device in a rigidstate has a shape of figure eight comprised of two arcs and twoconnected interconnecting sections. The resulting shape of theimplantable device in a rigid state which is in contact with the pylorusis substantially straight and hence does not exert an expanding force onthe pylorus, ensuring the long term stability of the implanted device.

In a further example all link (101, 113, 115, 117, 119) surfaces areatraumatic link surfaces made of titanium. In a further example theatraumatic properties of the links (101, 113, 115, 117, 119) areenhanced by a Teflon coating or overcoat. In a further example the links(101, 113, 115, 117, 119) are fabricated using additive manufacturingprocesses.

In a further example the release unit (105) includes an extractable pin(121) attaching the device closure pin (111) to the release unit (105)and removal of the extractable pin (121) releases the device closure pin(111) from the release unit (105).

FIG. 2A is an example of an implantable device link (FIG. 1A numerals101, 113, 115, 117, 119). A link (101) includes an attachment axis (203)and a pin cavity (205). The attachment axis (203) is configured toconnect to a pin cavity (201) in a second link so creating a closedcontour composed of a plurality of links (101, 113, 115, 117, 119) whereeach link (101, 113, 115, 117, 119) is connected to two other links(101, 113, 115, 117, 119) or to a link (101) on one side and either alock in unit (FIG. 1B 103) or release unit (FIG. 1B 105) on an opposingside. FIG. 2B is an example of a top view of a link (101) of theimplantable device. FIG. 2C is an example of a side view cross sectionof a link of the implantable device at cut line N-N from FIG. 2B. Thelink (101) includes an attachment axis (203) and a pin cavity (201). Thelink further includes an inclined side (205). In the flexible mode ofthe implantable device, one link (101) is connected to a second link(101) where the axis (203) of one link (101) is inserted in the pincavity of a second link (101). The links (101) are free to move aroundthe axle defined by their axis (203). The relative movement of the links(101) around the axle provides the required flexibility along one planeof an implantable device in the flexible mode. In the constrained modeinclined side (205) of one link (101) is pressed against opposing side(211) of adjacent connected link (101). The shape of the contour of theimplantable device in the constrained mode is determined by the relativeangle of the inclined side (205) of one link (101) and the opposing side(211) of the adjacent link (101) which is in contact with said inclinedside (205). In a further example the aforementioned relative anglevaries from link to link to configure a specific size shape of theclosed contour of the implantable device in the rigid mode.

Support recess (207 or 209) come into contact with support recess (209or 207) of an adjacent link at a preset maximum angle and provide aconstraint on the relative motion of the link (101) in the flexiblemode. In a further example the links comprise at least a base (220); oneor more connecting pins (203) and one or more vias (201). All links(FIG. 1A 101, 113, 115, 117, 119 and FIG. 2A 101) comprising theimplantable device and pins (203) and pin holes (205) are manufacturedconcurrently so that a pin (203) of one link (101) is situated in a pinhole (205) of an adjacent link (101) or lock in unit (FIG. 1A 103) orquick release unit (FIG. 1A 105) and providing a closed contour of links(101), lock in unit (FIG. 1A 103) and quick release unit (FIG. 1A 105)at the end of the additive manufacturing cycle.

In a further example the links are comprised of at least a base (220);one or more connecting axis (203) and one or more holes (201). In afurther example base (220) and a connecting axis (203) of one link (FIG.1B 101, 111, 113, 115, 117) which is located in a pin hole (201) of asecond link (FIG. 1B 101, 111, 113, 115, 117) are fabricatedconcurrently using additive manufacturing processes.

FIG. 3A is an example of a device closure pin (111) attached to arelease unit (105). The device closure pin (111) top side is configuredas a snap in segment. The snap in segment includes a recess (305) and anangled tip (309). In a further example, when the implantable device isin a flexible mode a chord (FIG. 1B 123) is connected to the top part ofthe angled tip (309). Pulling the chord (FIG. 1B 123), pulls the deviceclosure pin (111) into a receptacle where it is locked in place due tothe recess (305). The device closure pin (111) further includes one ormore quick release pin holes (307). FIG. 3B is an example of a side viewof a device closure pin attached to a release unit. The device closureunit (105) further includes an attachment pin (315) and attachment pincavity (311) which correspond to a link's (FIG. 2A 101) attachment pin(FIG. 2C 203) and attachment pin cavity (FIG. 2C 201). The pins are usedto attach links on either side of the device closure unit. The deviceclosure unit (105) further includes a quick release housing (301) andsecond pin hole (303). A device attachment pin is inserted into thequick release housing (301) and held in place by insertion of a quickrelease pin (FIG. 1B 121) through the second pin hole (303) and quickrelease pin hole (307) in the device closure pin (111). Prior toinsertion in the body the device closure pin (111) is attached to thequick release unit (105). The effective length of the device closure pin(111) is adjusted by a choice through which quick release pin hole (307)the quick release pin (FIG. 1B 121) will pass through and lock thedevice pin (111) in place. The effective length of the device closurepin (111) determines the contour shape when the implantable device is inthe rigid mode. In a further example the contour shape is configured tobe essentially flat for at least 1 link on either side of the quickrelease unit (105). Sleeve connection pin (321) is the anchor point fora chord connecting the implantable device to an intestine sleeve. FIG.3C is an example of a back view of a device closure pin attached to arelease unit.

FIG. 4A is an example of device closure pin (111) attached to areceptacle (401). FIG. 4B is an example of a side view of a deviceclosure pin (111) attached to a receptacle (401) and FIG. 4C is anexample of a top view of a device closure pin attached to a receptacle(401). In one example a receptacle (401) includes an outer ring (403) aplurality of spokes (405) which terminate short of the center of thereceptacle (401) and enable the angled tip (309) of the device closurepin (111) to traverse the receptacle (401) and then lock the deviceclosure pin (111) in place by extending into the device closure pinrecess (305). Examples of materials for manufacturing the receptacleinclude but are not limited to; stainless steel Titanium; stainlesssteel; Cobalt chrome, Nitinol alloy, thermoset plastics and similarmaterials or composition of said materials.

In a further example device closure pin (111) includes an angled tip(309) configured for insertion and lock-in into a receptacle (401) withan outer ring (405) and one or more spokes (403) and in a furtherexample the receptacle (401) is structured as slotted spring washer andconfigured to receive and hold a snap-in segment of device closure pin(111).

FIG. 5 is an example of a method of use of the implantable device in therigid state (151) to constrain movement in a body cavity. In one examplethe implantable device in the rigid state (151) is fixed in the stomach(511). An intestine sleeve (505) is attached with the sleeve chord (501)to the implantable device in the rigid state (151) and inserted into theintestine (513). In a further example the intestine sleeve (505)includes a wave anchor (503) which positions it the intestine sleeve inplace. FIG. 6A is an example of the wave anchor (503) in a foldedconfiguration and FIG. 6B is an example of the wave anchor in anexpanded configuration.

A number of examples have been described. Nevertheless, it will beunderstood that various modifications may be made without departing fromthe spirit and scope of the method. Accordingly, other examples arewithin the scope of the following claims:

What is claimed is:
 1. A method of using an implantable device,comprising: providing an implantable device including a plurality oflinks (113, 115, 117, 119), a device closure pin (111), a lock-in unit(103) attached and located between two links, and a quick release unit(105) attached and located between two links; and constructing theplurality of links (113, 115, 117, 119), lock-in unit (103) and releaseunit (105) in a closed contour, wherein the closed contour of theimplantable device, in a rigid state (151), is a figure eight comprisedof two arcs (125, 127) and two connected interconnecting sections (131,133).
 2. The method of claim 1 further comprising attaching the deviceclosure pin (111) to both the lock-in unit (103) and release unit (105)and holding the implantable device in a rigid state.
 3. The method ofclaim 1 wherein providing a plurality of links includes all linksurfaces being atraumatic surfaces comprised of titanium.
 4. The methodof claim 3 wherein the atraumatic surfaces of the links further includea polytetrafluoroethylene coating or overcoat.
 5. The method of claim 1further comprising inserting the device closure pin (111), including anangled tip (309) and lock-in, into a receptacle (401) with an outer ring(405) and one or more spokes (403).
 6. The method of claim 1 wherein theimplantable device is in a flexible state when the device closure pin(111) is coupled to the lock-in unit (103) or the quick release unit(105) and in a rigid state when the device closure pin (111) is attachedto both the lock-in unit (103) and the quick release unit (105).
 7. Themethod of claim 1 wherein using the quick release unit (105) with anextractable pin (121) attaching the device closure pin (111) to therelease unit (105) and removing the extractable pin (121) releases thedevice closure pin (111) from the release unit (105).
 8. The method ofclaim 1 wherein the links (113, 115, 117, 119) are fabricated usingadditive manufacturing processes.
 9. The method of claim 1 wherein thelinks (113, 115, 117, 119) include at least a base (220); an attachmentaxis (203) and one or more pin holes.
 10. The method of claim 9 whereina base (220) and attachment axis (203) of one link which is located in apin hole of a second link are fabricated concurrently using additivemanufacturing processes.
 11. The method of claim 1 wherein the deviceclosure pin (111) includes an angled tip (309) configured for insertionand lock-in into a receptacle (401) with an outer ring (405) and one ormore spokes (403).
 12. The method of claim 1 further comprising keepingthe implantable device in a rigid state (151) by closing the contour andwherein the contour is oval and comprised of two arcs (125, 127) and twointerconnecting sections (131, 133) wherein a radius of theinterconnecting sections (131, 133) is at least five times the radius ofthe arcs (125, 127).
 13. The method of claim 1 wherein the closedcontour of the implantable device in a rigid state is oval and comprisedof two arcs (125, 127) and two interconnecting sections (131, 133) wherethe two interconnecting sections (131, 133) are substantially straight.14. The method of claim 1 wherein the closed contour of the implantabledevice in a rigid state (151) is a figure eight comprised of two arcs(125, 127) and two connected interconnecting sections (131, 133).
 15. Amethod of using an implantable device comprising: providing animplantable device with a plurality of links (113, 115, 117, 119) andconstructing a closed loop wherein each link (113, 115, 117, 119) isconnected to two other links; and a device closure pin (111); whereinthe implantable device is flexible when only one side of device closurepin (111) is attached to a link and rigid when both sides of the deviceclosure pin (111) are attached to a link; and wherein at least one linkincludes a receptacle (401) with a slotted spring washer configured toreceive and hold a snap-in segment of the device closure pin (111). 16.The method of claim 15 wherein all surfaces of a plurality of links areatraumatic surfaces comprised of titanium and wherein atraumaticproperties of the links further include a polytetrafluoroethylenecoating or overcoat.
 17. The method of claim 15 wherein the links (113,115, 117, 119) are fabricated using additive manufacturing processes.18. The method of claim 15 wherein the links comprise at least a base(220); one or more connecting pins and one or more pin-holes.
 19. Themethod of claim 18 wherein base (220) and one or more connecting pinswhich are located in pin-holes of a second member and are fabricatedusing additive manufacturing processes.
 20. The method of claim 15wherein the device closure pin (111) includes a snap-in segmentconfigured for insertion and lock-in into a receptacle with one or moreholes.
 21. The method of claim 15 wherein at least one link includes aquick extractable pin (121) attaching the device closure pin (111) theat least one link and removal of the quick extractable pin (121)releases the device closure pin (111) from the at least one link.